QC Investigator III

Katalyst CRO; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Deviation Investigator Level III to lead investigations in a cGMP environment. The role requires strong RCA knowledge, ability to manage multiple projects, and excellent technical writing skills.

You will drive CAPA effectiveness, ensure timely resolutions, and mentor junior staff in a fast-paced setting. Ideal candidates have 5–10 years of related industry experience and a BS degree in biotechnology, biology, chemistry, or an equivalent field.

Qualifications

• BS Degree in Biotechnology, Biology, Chemistry or equivalent.
• Equivalent industry experience, 5–10 years.
• Strong written and verbal communication skills.
• Knowledge of RCA tools: Cause Mapping, Event & Casual Factor charting, 5 Why.

Responsibilities

• Share knowledge to enhance performance and build sustainable investigation teams.
• Aid in real-time decisions for deviation containment and investigative response.
• Manage moderate to high workloads with on-time delivery.
• Resume in-progress investigations with limited assistance from senior investigators.
• Provide direction on deviation approach and transfer knowledge to elevate team expertise.
• Aim for >80% Right First Time on customer deviation reviews.
• Drive effective CAPA to prevent recurrence.
• Perform investigations for complex events with leadership assistance.
• Perform other duties as assigned.

Skills

Inter-departmental collaboration

Strong written & verbal communication

Root cause analysis

Project management

Planning & organizing

Decision making

Education

BS Degree in Biotechnology/Biology/Chemistry or equivalent

Tools

Cause Mapping

Event & Casual Factor charting

5 Why

Job description

Job Description

The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

• Share knowledge to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing investigation teams.
• Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.
• Ability to manage moderate to high workloads with consistent on-time delivery.
• Ability to resume in-progress investigations with limited assistance from Sr. level investigators.
• Provide direction on deviation approach for the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
• Work to achieve >80% Right First Time on customer deviation reviews.
• Drive for effective CAPA such that deviations do not recur.
• Perform investigations for complex events with assistance from team leadership (as needed).
• Perform other duties as assigned.

Requirements

• Ability to work inter-departmentally and with customers.
• High level of area specific operations and technical skills.
• Demonstrates Error Prevention System (EPS) behaviors e.g. 3 way communication, questioning attitude, etc.
• Strong written and verbal communication skills.
• Utilizes multiple RCA tools including but not limited to Cause Mapping, Event and Casual Factor charting, and 5 Why.
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making, considering broad scope of factors.
• BS Degree(Biotechnology, Biology, Chemistry or equivalent).
• Equivalent industry experience, 5-10 years.